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FDA Expands EUA For Lilly's Bamlanivimab, Etesevimab To Include Post-exposure Prophylaxis For COVID

Eli Lilly and Company (LLY) Thursday said that the U.S. Food and Drug Administration has expanded the Emergency Use Authorization for bamlanivimab and etesevimab administered together to include post-exposure prophylaxis in certain individuals for the prevention of SARS-CoV-2 infection.

The neutralizing antibodies can now be used together to treat high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting, including a nursing home or prison.

The expanded authorization is based on data from BLAZE-2 that enrolled residents and staff at long-term care facilities, across the U.S. In this placebo-controlled Phase 3 study, bamlanivimab reduced the risk of contracting symptomatic COVID-19 by up to 80 percent in nursing home residents and up to 57 percent among residents and staff of long-term care facilities.

BLAZE-2 study was conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN).

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